Phase 4
N=90
Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory)
Back Pain Lower Back
Bottom Line
View on ClinicalTrials.gov: NCT01374269 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Visual Analogue Scale of Pain — 47.3; 45.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exercise program (Other); NSAID (Nonsteroidal anti-inflammatory drugs) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Rehabilitacion en Salud
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale of Pain |
17.8; 17.5 | — |
| PRIMARY Visual Analogue Scale of Pain |
17.8; 17.5 | — |
| PRIMARY Visual Analogue Scale of Pain |
17.8; 17.5 | — |
| PRIMARY Visual Analogue Scale of Pain |
17.8; 17.5 | — |
| SECONDARY Oswestry Disability Index |
13.8; 17.2 | — |
| SECONDARY Oswestry Disability Index |
13.8; 17.2 | — |
| SECONDARY Oswestry Disability Index |
13.8; 17.2 | — |
| SECONDARY Oswestry Disability Index |
13.8; 17.2 | — |
| SECONDARY Roland-Morris Questionnaire |
2.3; 2.5 | — |
| SECONDARY Roland-Morris Questionnaire |
2.3; 2.5 | — |
| SECONDARY Roland-Morris Questionnaire |
2.3; 2.5 | — |
| SECONDARY Roland-Morris Questionnaire |
2.3; 2.5 | — |
| SECONDARY Quality of Life, Change in Health |
78.0; 70.7 | — |
| SECONDARY Quality of Life, Change in Health |
78.0; 70.7 | — |
| SECONDARY Quality of Life, Change in Health |
78.0; 70.7 | — |
| SECONDARY Quality of Life, Change in Health |
78.0; 70.7 | — |
| SECONDARY Quality of Life, Bodily Pain |
74.1; 68 | — |
| SECONDARY Quality of Life, Bodily Pain |
74.1; 68 | — |
| SECONDARY Quality of Life, Bodily Pain |
74.1; 68 | — |
| SECONDARY Quality of Life, Bodily Pain |
74.1; 68 | — |
| SECONDARY Quality of Life, Emotional Performance. |
94.1; 93.9 | — |
| SECONDARY Quality of Life, Emotional Performance. |
94.1; 93.9 | — |
| SECONDARY Quality of Life, Emotional Performance. |
94.1; 93.9 | — |
| SECONDARY Quality of Life, Emotional Performance. |
94.1; 93.9 | — |
| SECONDARY Quality of Life, Physical Performance. |
84.3; 85.2 | — |
| SECONDARY Quality of Life, Physical Performance. |
84.3; 85.2 | — |
| SECONDARY Quality of Life, Physical Performance. |
84.3; 85.2 | — |
| SECONDARY Quality of Life, Physical Performance. |
84.3; 85.2 | — |
| SECONDARY Quality of Life, Physical Function. |
84.1; 82.6 | — |
| SECONDARY Quality of Life, Physical Function. |
84.1; 82.6 | — |
| SECONDARY Quality of Life, Physical Function. |
84.1; 82.6 | — |
| SECONDARY Quality of Life, Physical Function. |
84.1; 82.6 | — |
| SECONDARY Quality of Life, Social Function. |
88.6; 86 | — |
| SECONDARY Quality of Life, Social Function. |
88.6; 86 | — |
| SECONDARY Quality of Life, Social Function. |
88.6; 86 | — |
| SECONDARY Quality of Life, Social Function. |
88.6; 86 | — |
| SECONDARY Quality of Life, General Health Perceptions. |
73.4; 69.3 | — |
| SECONDARY Quality of Life, General Health Perceptions. |
73.4; 69.3 | — |
| SECONDARY Quality of Life, General Health Perceptions. |
73.4; 69.3 | — |
| SECONDARY Quality of Life, General Health Perceptions. |
73.4; 69.3 | — |
| SECONDARY Quality of Life, Mental Health. |
78.5; 76.9 | — |
| SECONDARY Quality of Life, Mental Health. |
78.5; 76.9 | — |
| SECONDARY Quality of Life, Mental Health. |
78.5; 76.9 | — |
| SECONDARY Quality of Life, Mental Health. |
78.5; 76.9 | — |
| SECONDARY Quality of Life, Vitality. |
70.3; 62.8 | — |
| SECONDARY Quality of Life, Vitality. |
70.3; 62.8 | — |
| SECONDARY Quality of Life, Vitality. |
70.3; 62.8 | — |
| SECONDARY Quality of Life, Vitality. |
70.3; 62.8 | — |
| SECONDARY PHQ-9 Patient Health Questionnaire (PHQ-9) Depression |
2.3; 3.1 | — |
| SECONDARY PHQ-9 Patient Health Questionnaire (PHQ-9) Depression |
2.3; 3.1 | — |
| SECONDARY PHQ-9 Patient Health Questionnaire (PHQ-9) Depression |
2.3; 3.1 | — |
| SECONDARY PHQ-9 Patient Health Questionnaire (PHQ-9) Depression |
2.3; 3.1 | — |
| SECONDARY Relapses of Lumbar Pain |
5.0; 20.5 | — |
| SECONDARY Relapses of Lumbar Pain |
5.0; 20.5 | — |
| SECONDARY Treatments Associated With Low Back Pain at 6 Months |
3; 14 | — |
| SECONDARY Missing Workdays |
0.2; 0.2 | — |
| SECONDARY Missing Workdays |
0.2; 0.2 | — |
| SECONDARY Missing Workdays |
0.2; 0.2 | — |
| SECONDARY Missing Workdays |
0.2; 0.2 | — |
| SECONDARY Medical Consultations. |
4; 4 | — |
| SECONDARY Medical Consultations. |
4; 4 | — |
| SECONDARY Medical Consultations. |
4; 4 | — |
Summary
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Eligibility Criteria
Inclusion Criteria
- Patients aged between 18 and 60 years old
- Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
- That have social security system
- Live in the metropolitan area
Exclusion Criteria
- Antecedents of spinal, pelvis or abdominal trauma
- Cancer
- Diabetes mellitus
- Steroids use
- Men and Women over 60 years
- Cauda equine syndrome
- Women and men with osteoporosis or compression fractures
- Suspicion of infection.
- Insidious onset, constitutional symptoms
- Intravenous drugs abuse
- HIV
- Immunosuppression or previous surgery
- Rheumatic diseases
- Urinary tract infections
- Neurological symptoms in lower limbs
- Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
- Deformities in the spine (scoliosis greater than 15º)
- History of peptic acid disease
- Renal failure
- Intake of anticoagulants or antiplatelet drugs
- Allergy to NSAIDs.
Data sourced from ClinicalTrials.gov (NCT01374269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.